AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 2CD3/CD19 HaploNCT00961142

Haploidentical Stem Cell Transplantation With CD3/CD19 Depletion and Reduced Intensity Conditioning in Patients With Acute Leukemia

A Phase 2 study testing Fludarabine, Thiotepa, Melphalan, Thymoglobuline (ATG) in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by University Hospital Tuebingen at 8 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Feasibility and toxicity of haploidentical allogeneic HCT after a reduced intensity conditioning regimen with CD3/CD19 depleted grafts. This study enrolls patients with acute leukemia in complete remission with an indication for allogeneic HCT but without a suitable HLA-identical donor Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Fludarabine, Thiotepa, Melphalan, Thymoglobuline (ATG)
How many people
23 participants
Where
8 sitesGermany
Study dates
Jun 2009to 30 Dec 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with either ALL or AML in CR with an indication for allogeneic HCT according to the following criteria:
  • AML: high risk patients with one or more of the following risk factors:
  • FLT-3 mutation
  • Complex cytogenetics
  • abn(3q), -5/5q-, -7/7q-, abn(12p), abn(17p)
  • Late CR > induction I
Show all 23Show fewer
  • Age >60
  • Patients in 2.CR
  • Secondary AML
  • Relapse after a preceding allogeneic HCT from an HLA-identical donor
  • ALL: high risk patients with one or more of the following risk factors:
  • Pro-B-ALL
  • Initial WBC >30.000/µL
  • CR after day 46 after Induction II
  • Complex cytogenetics, t(9,22), t(4,11)
  • Early or mature T-ALL
  • Initially refractory patients with late CR
  • Rising MRD level
  • Patients in 2. CR
  • Relapse after a preceding allogeneic HCT from an HLA-identical donor
  • No HLA-identical donor (not more than 1 antigen mismatch (9/10-Match) or more than 2 allelic mismatches by high-resolution typing). Critical cases should be discussed with the PI.
  • Age <=65, >=18 years
  • Karnofsky Index >60%

Who cannot join

  • Patients with >5% blasts in BM at the time of transplantation
  • Less than 3 months after preceding HCT
  • CNS involvement with disease
  • History of neurologic impairment such as: seizures, severe peripheral neuropathy, signs of leukoencephalopathy, CNS infection, multiple intrathecal chemotherapies, CNS irradiation. In case of heavy pretreatment with irradiation or intrathecal chemotherapy pretransplant CNS MRI and neurological consultation are mandatory
  • Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month.
  • Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher 2x upper limit of normal.
Show all 19Show fewer
  • Chronic active viral hepatitis
  • Ejection fraction <40 % on echocardiography
  • Patients with > grade II hypertension by CTC criteria
  • Creatinine clearance <50 ml/min
  • Respiratory failure necessitating supplemental oxygen or DLCO <30%
  • Allergy against murine antibodies
  • HIV-Infection
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter. (Women of childbearing potential must have a negative serum pregnancy test at study entry)
  • Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
  • Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
  • Patients unwilling or unable to comply with the protocol
  • Unable to give informed consent
  • Enrollment in an other trial interfering with the endpoints of this study

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Germany8 sites

  • University of Dresden Medical Center

    Dresden, D-01307

  • Center for Marrow Transplantation, University of Essen

    Essen, 45122

  • Medical Center University of Halle

    Halle, 06120

  • Medical Center University of Hamburg

    Hamburg, 20246

  • Medical Center University of Muenster

    Münster, 48149

  • South West German Cancer Center, University of Tuebingen Medical Center

    Tübingen, 72076

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191

  • University of Wuerzburg Medical Center

    Würzburg, D-97070

Other trials in Germany

About this study

Official title: Multicenter Phase II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts After a Reduced Intensity Conditioning Regimen for Adult Patients With Acute Leukemia

Feasibility and toxicity of haploidentical allogeneic HCT after a reduced intensity conditioning regimen with CD3/CD19 depleted grafts. This study enrolls patients with acute leukemia in complete remission with an indication for allogeneic HCT but without a suitable HLA-identical donor

Being tested
Fludarabine, Thiotepa, Melphalan, Thymoglobuline (ATG)
Keywords
Haploidentical Transplantation, CD3/CD19 Depletion, AML, ALL, Reduced Intensity Conditioning
Medical subject headings
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fludarabine, Thiotepa, Melphalan, Thymoglobuline (ATG)Drug

    Conditioning with Fludarabine 30 mg/m2/24h day-8 to -4, Thiotepa 2x5 mg/kg day -3, Melphalan 60 mg/m2 day -2 to -1 and Thymoglobuline (ATG)1.5mg/kg/day day -9 to -6. PBSC depleted of CD3 and CD19 cells by immunomagnetic depletion on CliniMACS.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of treatment related mortality after haploidentical HCT

    Cumulative Incidence of treatment related mortality

    Measured: 1 year after HCT

Secondary outcomes (4)

  1. overall survival

    by Kaplan-Meier

    Measured: 1, 2 and 5 years after inclusion

  2. Evaluate Engraftment

    Measured: One year after HCT

  3. Evaluate Toxicity

    Measured: One year after HCT

  4. Evaluate Disease Free Survival

    Measured: 1, 2 and 5 years after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2009 (estimated)
  2. Study startJun 2009
  3. Primary completion30 Dec 2015
  4. Study completion30 Dec 2015

Why it stopped: slow recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00961142
Sponsor's protocol ID
EudraCT 2007-006016-33
Acronym
CD3/CD19 Haplo
Status last verified
Jun 2022
First submitted
17 Aug 2009
Last updated
5 Jul 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Bethge WA, Faul C, Bornhauser M, Stuhler G, Beelen DW, Lang P, Stelljes M, Vogel W, Hagele M, Handgretinger R, Kanz L. Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning: an update. Blood Cells Mol Dis. 2008 Jan-Feb;40(1):13-9. doi: 10.1016/j.bcmd.2007.07.001. Epub 2007 Sep 14.

    PubMed 17869547

  • Bethge WA, Haegele M, Faul C, Lang P, Schumm M, Bornhauser M, Handgretinger R, Kanz L. Haploidentical allogeneic hematopoietic cell transplantation in adults with reduced-intensity conditioning and CD3/CD19 depletion: fast engraftment and low toxicity. Exp Hematol. 2006 Dec;34(12):1746-52. doi: 10.1016/j.exphem.2006.08.009.

    PubMed 17157172

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fludarabine, Thiotepa, Melphalan, Thymoglobuline (ATG) in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by University Hospital Tuebingen at 8 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: slow recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of treatment related mortality after haploidentical HCT (time frame: 1 year after HCT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00961142, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in